The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency’s Safer Technologies Program.
FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of treatments or diagnostics. These are aimed at underlying diseases or conditions that are less serious than those eligible for the breakthrough program.
These devices should improve on existing diagnostics’ or treatments’ safety by reducing adverse events, device failures, use-related hazards or user errors or by improving the safety of other devices or interventions.
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